Baseline Predictors of Serious Adverse Events at One Year Among Patients With Bipolar Disorder in STEP-BD

OBJECTIVE: Little is known about serious adverse events that occur in the context of clinical care for bipolar disorder. This study examined predictors of serious adverse events in a large cohort of patients with bipolar disorder. METHODS: Types and frequency of serious adverse events were tabulated on the basis of data from the first 1,000 participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). STEP-BD follows a large cohort of patients longitudinally. Treatments are provided as deemed most appropriate by the treating psychiatrist. Logistic regression was used to identify variables present at study entry that were associated with the occurrence of a serious adverse event within one year. RESULTS: A total of 161 serious adverse events were reported among 118 participants. The most frequent serious adverse event was hospitalization for suicidal ideation (44 participants, or 27 percent). A greater number of previous psychiatric medications was predictive of the occurrence of a psychiatric serious adverse event among participants who had less than one year of study follow-up data. A history of psychosis, current substance abuse, lower household income, and a fully syndromic baseline mood state were associated with the occurrence of a psychiatric serious adverse event among participants who had one full year of follow-up data. CONCLUSIONS: These data identify clinical and demographic factors that warrant closer clinical follow-up, because these factors may be predictive of poor outcomes in the following year, even in the context of expert care.